文献类型：期刊文献

中文题名：离子色谱法测定盐酸阿比朵尔中残留的二甲胺含量

英文题名：Determination of the residual dimethylamine in arbidol hydrochloride by ion chromatography

作者：方琳美[1];胡咪[1];陈爱连[1];徐雪萍[1];施超欧[1]

机构：[1]华东理工大学分析测试中心,上海200237

年份：2016

卷号：36

期号：10

起止页码：1852

中文期刊名：药物分析杂志

外文期刊名：Chinese Journal of Pharmaceutical Analysis

收录：CSTPCD;;北大核心:【北大核心2014】；CSCD:【CSCD2015_2016】；

语种：中文

中文关键词：抗病毒药;盐酸阿比朵尔;二甲胺残留;杂质检测;安全监测;离子色谱

外文关键词：antiviral drug;arbidol hydrochloride;residue of dimethylamine;impurity detection;safety monitoring;ion chromatography

摘要：目的:利用离子色谱法建立盐酸阿比朵尔中残留二甲胺的含量测定方法。方法:采用阳离子交换柱[Dionex Ion Pac CG16(5 mm×50 mm)+C S16(5 mm×250 mm)],以30 mmol·L^(-1)甲基磺酸为淋洗液,流速1.0 m L·min^(-1),柱温30℃,电导检测器检测,抑制器为CSRS 300(4 mm)。结果:二甲胺质量浓度在0.031~4.0 mg·L^(-1)范围内线性关系良好(r=0.999 9),二甲胺对照品溶液(1 mg·L^(-1))连续6次进样,保留时间、峰高、峰面积的RSD都小于1.5%,本检测方法的检出限为0.001 mg·L^(-1),定量限为0.004 mg·L^(-1),样品的日内和日间RSD分别为1.7%和2.8%,3个水平的加标提取回收率在94.7%~105.0%之间,3个批次样品中残留二甲胺的含量分别为0.021 2%、0.023 1%、0.020 7%。结论:本方法经方法学验证,可有效监控盐酸阿比朵尔的质量。
Objective：To establish a determination method for the residual dimethylamine in arbidol hydrochloride by ion chromatography. Methods： The determination was carried on a cation exchange column [Dionex Ion Pac CG16（5 mm×50 mm）＋CS16（5 mm×250 mm）] with 30 mmol·L-1methanesulfonic acid solution as eluent by electrical conductivity detector. The flow rate was 1.0 m L·min-1,the column temperature was 30 ℃,and the suppressor was CSRS 300（4 mm）. Results： There was a good linearity over the range of 0.031-4.0 mg·L-1 with the correlation coefficient higher than 0.999 9. With 6 consecutive samples of dimethylamine reference substance solution（1 mg·L-1）,the RSD of retention time,peak height and peak area were all below 1.5%. The detection limit of the method was 0.001 mg·L-1,and the quantitative limit was 0.004 mg·L-1. Intra-day and inter-day RSDs of samples were 1.7% and 2.8%. Three levels of spiked recovery were between 94.7% and 105.0%. The content of the residual dimethylamine in three batches of samples were 0.021 2%,0.023 1%,and 0.020 7%,respectively.Conclusion：The method is proved by methodology validation that it can be effectively used in quality control of arbidol hydrochloride.